BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNIFUSE BONE GRAFT

    MDR report key: 5066562 · Received September 9, 2015

    Report

    Report Number
    2246640-2015-00008
    Event Type
    Injury
    Date Received
    September 9, 2015
    Report Date
    August 11, 2015
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MQV
    PMA / PMN Number
    K082615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PATIENT MEDICAL INFORMATION OR DEVICE INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; THEREFORE WE ARE NEITHER ABLE TO REVIEW ANY APPLICABLE DEVICE HISTORY RECORDS, NOR TO DETERMINE WHETHER THE SUSPECT DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013: THE PATIENT PRESENTED FOR AN OFFICE VISIT WHERE PATIENT DEMOGRAPHICS WERE NOTED. ON (B)(6) 2013: THE PATIENT UNDERWENT FOR X-RAY IMAGING. ON (B)(6) 2013: THE PATIENT PRESENTED WITH DEGENERATIVE DISEASE DUE TO HISTORY OF LAMINOTOMY AT L3-4. DIAGNOSIS: DISC HERNIATION AT L4-L5.; FACET ARTHROPATHY AT L1-S1; SPINAL STENOSIS: L4-L5. ON (B)(6) 2013: THE PATIENT PRESENTED FOR AN OFFICE VISIT AND WAS ASSESSED FOR PAIN INTENSITY, PERSONAL CARE, LIFTING, WALKING, SITTING, STANDING, SLEEPING, SEX LIFE, SOCIAL LIFE, TRAVELING. ON (B)(6) 2013: THE PATIENT UNDERWENT FOLLOWING SURGICAL TREATMENT: DECOMPRESSION SURGERY, L3-L4 (LAMINECTOMY), L4-L5 (LAMINECTOMY); DISKECTOMY, L3-L4, L4-L5; POSTERIOR FUSION: POSTERIOR INSTRUMENTATION + TLIF (L3-L5); WITH SURGICAL APPROACH AS: MINIMAL ACCESS SURGERY WITH LOCAL AUTOLOGOUS BONE GRAFTING. ON (B)(6) 2014: THE PATIENT PRESENTED FOR AN OFFICE VISIT AND WAS ASSESSED FOR PAIN INTENSITY, PERSONAL CARE, LIFTING, WALKING, SITTING, STANDING, SLEEPING, SEX LIFE, SOCIAL LIFE, TRAVELING. ON (B)(6) 2014: THE PATIENT PRESENTED FOR AN OFFICE VISIT AND WAS GRADED UNDER LENKE FUSION GRADES AS POSTERIOR FUSION GRADE: GRADE I. LATER, PATIENT ALSO UNDERWENT FOR X-RAY IMAGING. ON (B)(6) 2015: THE PATIENT PRESENTED WITH COMPLAINT OF L4/5 PAIN WITH WEAKNESS. FOR WHICH PATIENT UNDERWENT EMG/NERVE CONDUCTION STUDY WHICH CONFIRMED L5-S1 RADICULOPATHY. ON (B)(6) 2015: THE PATIENT UNDERWENT TREATMENT WITH LEFT L4/5 REVISION OF LAMINOTOMY WITH LEFT L5 SCREW REVISION AND LEFT L5/S1 REVISION LAMINOTOMY. ON (B)(6) 2015: THE PATIENT PRESENTED FOR AN OFFICE VISIT AND WAS GRADED UNDER LENKE FUSION GRADES AS POSTERIOR FUSION GRADE: GRADE I. LATER, PATIENT ALSO UNDERWENT FOR X-RAY IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594540 MAGNIFUSE BONE GRAFT FILLER, BONE VOID, CALCIUM COMPOUND MQV OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention